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Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)

NCT01520714 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-05-26

Study results available
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Summary

The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • James B DeVille, M.D. · Baylor Research Institute - The Heart Hospital Baylor Plano

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520714 on ClinicalTrials.gov